ASTM F1980 07 PDF
Buy ASTM F (R) GUIDE FOR ACCELERATED AGING OF STERILE BARRIER SYSTEMS FOR MEDICAL DEVICES from SAI. Time versus Temperature. – Relationship. – Affects on products. • Case Studies. • ASTM F – Changes to revision. • Real Time Aging. 1 This guide is under the jurisdiction of ASTM Committee F02 on Primary Last previous edition approved in as F – 07().
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Define aging test time intervals including time zero. Refer to Practice D for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions.
If you have questions about our online quoting process or other questions or need assistance, call RMTS at Evaluate package, or package performance, or both, ff1980 real time aging relative to the initial package requirements.
Therefore, some axtm an extra month to the aging study to allow for sterilization, etc. ASTM-F Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices The introduction of new or modified products to the marketplace requires the assurance that they can be stored for an extended period one year, two years, etc.
To receive an Official Detailed Quote, please fill-in the following fields. For more information visit www. Accelerated Aging Temperature Higher temp. Accelerated aging studies can provide an alternative means.
Extracted information from ASTM F testing may be used to support expiration date claims for medical device sterile barrier systems. Historical Version s – view previous versions of standard.
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Fed-Ex Overnight, Account number. Select the Q10 value Define the desired shelf life of the package marketing and product needs, etc. More aggressive AAFs may be used with documented evidence to show a correlation between real time and accelerated aging.
Evaluate the package performance after accelerated aging relative to the initial package requirements. However, due to market conditions in which products become obsolete in a short time, and the need to get new products to market in the shortest possible time, real time aging studies do not meet this objective. Please fill-in your Input Temperatures and select the Q10 value. Shelf Life Study Equivalent. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.
The resulting creation of an expiration date or shelf life is based on the use of a conservative estimate of the aging factor for example, Q 10 and is tentative until the results of real time aging studies are completed on the sterile barrier system. Fed-Ex 2 nd day, Account number. Stability testing using accelerated aging protocols shall be regarded as sufficient evidence for claimed expiry date until data from real time aging studies are available. Accelerated Aging Test Results. Work Item s – proposed revisions of this standard.
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Asstm Humidity RH is not a factor in the Arrhenius equation. The introduction of new or modified products to the marketplace requires the assurance that they can be stored for an extended period one year, two years, etc. The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide.
ASTM-F – Accelerated Aging – Medical Package Testing
The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are:. ASTM F procedure for accelerated aging is comprised of the following: Real time studies must be carried out to the claimed shelf life of the product and be performed to their completion. Define package material properties, seal strength and integrity tests, sample sizes, and acceptance criteria.
Ast, samples at TAA. Ambient Temperature Warehouse Temperature Higher temp.
For example, a 12 month shelf life is simulated based on 13 months. Pricing includes monthly temperature graph reports. The expiry date of a medical product is commonly based on its manufacture date. Link to Active This link will always route to the current Active version of the standard.
ASTM F – 07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
UPS Ground, Account number. Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. The sterile barrier system shall maintain sterility to the point of use or until the expiry date. Standards for Accelerated Aging The primary accelerated aging standards pertaining to sterile barrier systems for medical devices are: Please fill out this form and return with your Product Submission. To ensure that accelerated aging studies do truly represent real time effects, real time aging studies must be conducted in parallel to accelerated studies.
If a different Temperature and or Temperature Humidity condition is required than listed above or more then 30 cubic feet of boxes, contact RMTS for Pricing at Please ship all samples with this form to: Try out our Accelerated Aging Calculator!
Online Quote System – Accelerated Aging.